PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 4

Conditions: Post-traumatic Stress Disorder

Treatments: Drug: Sertraline; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT02520726

UUtahIRB0062412

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD).

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Victim of a traumatic event leading to personal injury
• Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward
• Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.

Exclusion criteria

• Age < 18
• Pregnant women, lactating women, or women not using acceptable form of birth control
• Epilepsy or head trauma resulting in seizures
• Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior
• Current/previously diagnosed PTSD
• History of hypersensitivity to sertraline
• Trauma occurring > 7 days prior to likely first treatment in the randomization phase of the trial.
• Unable to provide informed consent for participation in the study protocol.
• Patient at high risk of recurrent bleeding despite surgical stabilization
• Patient with a history of serotonin syndrome
• Patient non-fluent in English
• Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI, mirtazapine, or trazodone in excess of 100mg per day)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Sertraline

Experimental group

Description:

Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration

Treatment:

Drug: Sertraline

Placebo

Placebo Comparator group

Description:

Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.

Treatment:

Drug: Placebo oral capsule